U.S. patent number 6,022,335 [Application Number 09/108,815] was granted by the patent office on 2000-02-08 for implantable hemodialysis triple port assembly.
Invention is credited to Hossein Ramadan.
United States Patent |
6,022,335 |
Ramadan |
February 8, 2000 |
Implantable hemodialysis triple port assembly
Abstract
An implantable dialysis connection assembly for connecting first
and second catheters positioned with a vein to first and second
terminals of a dialysis machine. The assembly includes a housing
having first, second and third recesses extending into a face side
thereof. A first port is positioned within the first recess for
receiving the first terminal and retaining an end of the first
terminal within the first recess. A second port is positioned
within the second recess for receiving the second terminal and
retaining an end of the second terminal within the second recess. A
third port is positioned within the third recess for connecting to
a supply of heparin for deposit within the third recess. The third
port is connected to the first port for supplying heparin thereto
by a first conduit and the third port is connected to the second
port for supplying heparin thereto by a second conduit. First and
second connection devices connect the first and second ports to the
first and second conduits, respectively. In operation, the first
terminal causes blood to be removed from the vein through the first
catheter and first recess for delivery to and detoxification by the
dialysis machine and the second terminal causes detoxified blood to
be returned to the vein through the second recess and second
catheter, said heparin being supplied to said first and second
recesses during dialysis for preventing the blood passing through
said first and second recesses from clotting and thereby clogging
the first and second terminals.
Inventors: |
Ramadan; Hossein (Syosset,
NY) |
Family
ID: |
22324198 |
Appl.
No.: |
09/108,815 |
Filed: |
July 1, 1998 |
Current U.S.
Class: |
604/93.01;
604/175; 604/5.04 |
Current CPC
Class: |
A61M
39/0208 (20130101); A61M 2039/0211 (20130101); A61M
2202/0478 (20130101) |
Current International
Class: |
A61M
39/02 (20060101); A61M 011/00 () |
Field of
Search: |
;604/93,174,175,82,86,4 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: McDermott; Corrine
Attorney, Agent or Firm: Kroll; Michael I
Claims
What is claimed is new and desired to be protected by Letters
Patent is set forth in the appended claims:
1. An implantable dialysis connection assembly for connecting first
and second catheters positioned with a vein in a patients body to
first and second terminals of a dialysis machine, said implantable
dialysis connection assembly comprising:
a) a housing including a face side, and first, second and third
recesses extending into said face side;
b) a first port positioned within said first recess for receiving
the first terminal and retaining an end of the first terminal
within said first recess;
c) a second port positioned within said second recess for receiving
the second terminal and retaining an end of the second terminal
within said second recess;
d) a third port positioned within the third recess for connecting
to a supply of heparin for deposit within the third recess;
e) a first conduit extending between said first and third recesses
for supplying heparin from said third recess to said first
recess;
f) a second conduit extending between said second recess and said
third recess for supplying heparin from said third recess to said
second recess;
g) first means extending from said first recess for connecting said
first recess to the first catheter; and
h) second means extending from said first recess for connecting
said second recess to the second catheter, wherein blood is removed
from the vein through the first catheter, said first connecting
means and said first recess and through the first terminal retained
within said first recess to the dialysis machine and blood is
returned to the vein through the second terminal, said second
recess, said second connecting means and the second catheter, said
heparin being supplied to said first and second recesses during
dialysis for preventing the blood passing through said first and
second recesses from clotting and thereby clogging the first and
second terminals.
2. The implantable dialysis connection assembly as recited in claim
1, wherein the first and second terminals each include a needle
extending therefrom and said first and second ports each receive a
needle of a respective one of the first and second terminals
therein.
3. The implantable dialysis connection assembly as recited in claim
2, further comprising a first entrance extending between said first
recess and said first means for connecting and a second entrance
extending between said second recess and said second means for
connecting.
4. The implantable dialysis connection assembly as recited in claim
3, further comprising a first hollow protrusion extending from said
first entrance for connection to said first means for connection
and a second hollow protrusion for connecting to said second means
for connecting.
5. The implantable dialysis connection assembly as recited in claim
4, wherein said first protrusion includes a thread spiraling
therearound and said first means for connecting is hollow and
includes a thread spiraling around an inner side thereof for mating
with said thread spiraling around said first protrusion.
6. The implantable dialysis connection assembly as recited in claim
5, wherein said second protrusion includes a thread spiraling
therearound and said second means for connecting is hollow and
includes a thread spiraling around an inner side thereof for mating
with said thread spiraling around said second protrusion.
7. The implantable dialysis connection assembly as recited in claim
6, wherein the first catheter is secured within said inner side of
said first means for connecting and the second catheter is secured
within said inner side of said second means for connecting.
8. The implantable dialysis connection assembly as recited in claim
7, further comprising a first compression sleeve positioned between
said inner side of said first means for connecting and the first
catheter and a second compression sleeve positioned between said
inner side of the second means for connecting and said second
catheter.
9. The implantable dialysis connection assembly as recited in claim
8, wherein said first and second ports have a surface area of a
size able to provide a large number of insertion points thereby
allowing an area time to heal after puncture with a needle.
10. The implantable dialysis connection assembly as recited in
claim 2, wherein said first and second ports each have a thickness
and said first and second recesses each have a depth, said
thickness of said first and second ports being less than the depth
of said first and second recesses, respectively.
11. The implantable dialysis connection assembly as recited in
claim 10, wherein a pool is formed in said first recess below said
first port and a pool is formed in said second recess below said
second port.
12. The implantable dialysis connection assembly as recited in
claim 11, wherein said first and second ports are formed of a
rubberized self sealing silicone material.
13. The implantable dialysis connection assembly as recited in
claim 12, wherein said first and second ports each include a
defining wall, said defining wall of said first and second ports
being coated with a material able to prevent a needle inserted
therein from piercing the defining wall.
14. The implantable dialysis connection assembly as recited in
claim 13, wherein the needle extending from the first terminal
extends through said first port and into said pool formed in said
first recess upon insertion and the needle extending from the
second terminal extends through said second port and into said pool
formed in said second recess upon insertion.
15. The implantable dialysis connection assembly as recited in
claim 1, wherein said assembly is implanted positioned below
subcutaneous tissue in a left subclavicular area of the patient's
body.
16. The implantable dialysis connection assembly as recited in
claim 15, further comprising means extending from said housing for
securing said assembly within the body of the user.
17. The implantable dialysis connection assembly in claim 16,
wherein said means for securing is at least one of suchered and
stapled to the subcutaneous tissue in the patient's body.
18. The implantable dialysis connection assembly as recited in
claim 1, wherein said third port is formed of a rubberized self
sealing silicone material.
19. The implantable dialysis connection assembly as recited in
claim 1, further comprising means extending from said housing for
securing said assembly within the body of the user.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to dialysis access, and can
be used as an alternative, to A-V Fistula, A-V Graft and external
catheters and, more specifically, to an implantable hemodialysis
triple port assembly which will provide a cosmetically appealing
apparatus for long term dialysis patients, a fault tolerant
apparatus for health care professionals who sometimes fail to flush
the catheter with a heparinized solution after each use; and
relieve overburdened doctors and hospitals from repeated surgery
required for creation of arteriovenous fistulas, arteriovenous
grafts and the treatment of their complications, such as clotting,
usually requiring one to three hospitalizations per patient per
year to either declot the graft or fistula or create a new one. The
implantable hemodialysis triple port assembly will also eliminate
the need for an external dialysis catheter while preventing
problems such as frequent clotting, infection and inconvenience to
the patient associated therewith.
2. Description of the Prior Art
Hemodialysis acts to purify the blood by passing it through a
dialysis machine at a rate of 300-500 cc per minute. In order to
perform this procedure two (2) large needles (at least 16G) are
required for piercing a vein or graft (called angio-access) of
sufficient size to provide an appropriate flow of blood. One needle
will act to withdraw blood from the patient for delivery to the
dialysis machine and the other needle will act to return the
purified blood from the dialysis machine to the patient. Each
hemodialysis session usually lasts 2-4 hours and must be performed
three times a week over the course of the patient's life.
The veins of the arms are not large enough to accommodate the
withdrawal of 300-500 cc of blood per minute extracted by the
dialysis machines. Therefore, the veins in the arm must be enlarged
by creating a fistula between an artery and vein (A-V Fistula).
This may be performed in only a small percentage of dialysis
patients due to the small or fibrotic veins associated with renal
failure patients making them unsuitable for creation of a fistula.
Furthermore, when the fistula has been successfully created a
period of 4-8 weeks is needed in order for the fistula to mature
before it can be used for dialysis.
A second option for angio access is creating an arterial-venous
graft. This is performed using a synthetic tube, requires a patient
to remain in the hospital for several days and takes 1-3 weeks
before the graft can be used. There is also a high rate of
complication due to clotting, infection and arm swelling associated
with this procedure. Thus, declotting and frequent replacement of
the graft are normally required.
The third option is implanting an external temporary catheter to be
used until the A-V Fistula or shunt is ready for use. This
procedure also has pitfalls such as inconvenience to the patient as
it remains outside the skin, frequent infection and the need for
the catheter to be replaced.
Numerous types of devices for aiding in dialysis treatment have
been provided in the prior art. For example, U.S. Pat. Nos.
4,846,806; 4,892,518; 4,950,259 and 5,037,385 all are illustrative
of such prior art. While these units may be suitable for the
particular purpose to which they address, they would not be as
suitable for the purposes of the present invention as heretofore
described.
U.S. Pat. No. 4,846,806
Inventor: Bruce D. Wigness et al.
Issued: Jul. 11, 1989
An implantable intravascular access system, including an
implantable, catheter obturator controller manifold for use with an
implantable intravascular catheter. The catheter includes a lumen,
having an expanded state and a normal state, an obturator, and an
obturator plenum having an inflated state and a contracted state. T
he lumen can be closed or opened by hydraulically actuating the
expansion or contraction of the obturator plenum when the lumen is
in the normal state. When the obturator plenum is expanded to its
inflated state, the obturator substantially blocks the lumen such
that substantially no fluid can pass through the lumen when the
lumen is in its normal state. The manifold comprises a housing, a
receiving mechanism for receiving the catheter, an actuating
mechanism for hydraulically actuating the expansion or contraction
of the plenum, and a first entry mechanism for entering the
housing.
U.S. Pat. No. 4,892,518
Inventor: James R. Cupp et al.
Issued: Jan. 9, 1990
Hemodialysis port assembly including a port and a catheter
assembly. The port includes an inlet septum subtended by an inlet
plenum and an outlet septum subtended by an outlet plenum. The
catheter assembly includes an inlet channel connected to the inlet
plenum and an outlet channel connected to the outlet plenum. The
port and catheter assembly are completely implanted in the chest of
a patient with the port subcutaneous and the end of the catheter
assembly remote from the port injected into the subclavian vein.
The blood flow in this vein is in the direction away from the end
of the catheter assembly. Near this remote end the catheter
assembly or the inlet channel terminates in an outlet valve. Each
of these valves is essentially a flapper on which the blood is
incident in a generally perpendicular direction so that its flow is
substantially unimpeded. The outlet valve is spaced a small but
effective distance from the inlet valve in the downstream direction
of the flow to toxified blood through the outlet channel. In
practice of this invention, the detoxified blood from an artificial
kidney is supplied to the vein through a hypodermic needle which
penetrates the inlet septum, the inlet plenum, the inlet channel
and the inlet valve and toxified blood is supplied from the vein to
the artificial kidney through the outlet valve, the outlet channel,
the outlet plenum and an outlet needle which penetrates the outlet
septum. The spacing of the outlet valve from the inlet valve
suppresses short circuit flow of detoxified blood from the inlet
branch to the outlet branch.
U.S. Pat. No. 4,950,259
Inventor: Denis F. Geary et al.
Issued: Aug. 21, 1990
A double lumen flexible catheter for peritoneal dialysis comprises
a double lumen structure with inner and outer tubes. The outer tube
has a plurality of openings the inner tube being stretched in
tension to prevent kinking of the catheter. The inner tube has a
single outlet at the free end of the catheter. The tubing for the
catheter is sufficiently flexible to permit the catheter to lie
loosely and freely in the body cavity. Treatment fluids are
delivered to the peritoneal cavity through the inner tube and
removed via the outer tube.
U.S. Pat. No. 5,037,385
Inventor: Paul O'Byrne
Issued: Aug. 6, 1991
A wholly implantable continuous ambulatory peritoneal dialysis
system comprises a first part including tubing for location as an
access catheter affording a flowpath for dialyzing solution from a
subcutaneous portal, accessible by percutaneous needle, to the
peritoneal cavity, and a second part including a pump and a further
tubing serially interconnectable for location as a shunt affording
a flowpath for the solution, following dialysis, from the cavity to
the bladder, the pump being operable under control by the patient
to effect the shunt flow.
SUMMARY OF THE PRESENT INVENTION
The present invention relates generally to devices for connecting a
dialysis machine to a patient in need of hemodialysis and, more
specifically, to an implantable device, placed under the
subcutaneous tissue in the left or right subclavicular area and
connected to two catheters inserted percutaneously into the
superior vena cava via subclavian or internal jugular veins. The
implantable device may be connected to a dialysis machine by
insertion of two 16G anti-coring needles into the ports of the
implantable device and connecting the anti-coring needles to the
dialysis machine.
A primary object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
that will overcome the shortcomings of prior art devices.
Another object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
which is cosmetically appealing to the user while allowing the user
to assume a normal life style between dialysis treatments without
the risk of epidermal infection normally associated with tubes
providing external access to implanted catheters.
A further object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
including identical arterial and venous ports which are easily
locatable and discernible by application of light pressure to the
skin with a hand.
A yet further object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
wherein the arterial and venous ports are accessible using right
angle anti-coring needles attached to the dialysis machine.
A still further object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
including a third heparin port connected to both the arterial and
venous ports for storing a supply of heparin therein and supplying
the heparin to the arterial and venous ports.
A further object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
wherein the arterial and venous ports have a surface area of a size
able to provide a large number of insertion points thereby allowing
an area time to heal after puncture with the needle.
A further object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
wherein the heparin is supplied to the arterial and venous ports by
osmosis and acts as an anti-clotting mechanism.
Another object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
wherein the arterial, venous and heparin ports are formed from a
self sealing material such as rubberized silicone for preventing
the release of any fluids therefrom except through the needle
inserted therein.
A still further object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
wherein each of the arterial, venous and heparin ports are lined
with a suitably dense material for preventing the needle from
piercing the walls of the port.
Another object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
that is simple and easy to use.
A still further object of the present invention is to provide an
implantable assembly for connecting a dialysis machine to a patient
that is economical in cost to manufacture.
Additional objects of the present invention will appear as the
description proceeds.
An implantable dialysis connection assembly for connecting first
and second catheters positioned with a vein to first and second
terminals of a dialysis machine is disclosed by the present
invention. The assembly includes a housing having first, second and
third recesses extending into a face side thereof. A first port is
positioned within the first recess for receiving the first terminal
and retaining an end of the first terminal within the first recess.
A second port is positioned within the second recess for receiving
the second terminal and retaining an end of the second terminal
within the second recess. A third port is positioned within the
third recess for connecting to a supply of heparin for deposit
within the third recess. The third port is connected to the first
port for supplying heparin thereto by a first conduit and the third
port is connected to the second port for supplying heparin thereto
by a second conduit. First and second connection devices connect
the first and second ports to the first and second conduits,
respectively. In operation, the first terminal causes blood to be
removed from the vein through the first catheter and first recess
for delivery to and detoxification by the dialysis machine and the
second terminal causes detoxified blood to be returned to the vein
through the second recess and second catheter, said heparin being
supplied to said first and second recesses during and after
dialysis for preventing the blood passing through said first and
second recesses from clotting and thereby clogging the first and
second terminals.
To the accomplishment of the above and related objects, this
invention may be embodied in the form illustrated in the
accompanying drawings, attention being called to the fact, however,
that the drawings are illustrative only, and that changes may be
made in the specific construction illustrated and described within
the scope of the appended claims.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
Various other objects, features and attendant advantages of the
present invention will become more fully appreciated as the same
becomes better understood when considered in conjunction with the
accompanying drawings, in which like reference characters designate
the same or similar parts throughout the several views.
FIG. 1 is a front perspective view of the implantable assembly for
connecting a dialysis machine to a patient of the present invention
positioned under subcutaneous tissue in the left subclavicular area
of a patient and connected to two catheters inserted percutaneously
into the superior vena cava via the subclavian veins;
FIG. 2 is an enlarged top view of the implantable assembly for
connecting a dialysis machine to a patient of the present
invention;
FIG. 3 is a side perspective view of the implantable assembly for
connecting a dialysis machine to a patient of the present
invention;
FIG. 4 is a exploded top perspective view of the implantable
assembly for connecting a dialysis machine to a patient of the
present invention;
FIG. 5 is a side perspective view of the ports of the implantable
assembly for connecting a dialysis machine to a patient of the
present invention removed from the housing and including right
angle anti-coring needles extending therefrom;
FIG. 6 is a side cross-sectional view of the implantable assembly
for connecting a dialysis machine to a patient of the present
invention;
FIG. 7 is an exploded side view of the catheter connection port of
the implantable assembly for connecting a dialysis machine to a
patient of the present invention taken within the circle labeled 7
in FIG. 6;
FIG. 8 is an exploded view of the end of the catheters of the
implantable assembly for connecting a dialysis machine to a patient
of the present invention; and
FIG. 9 is an exploded view of the end of the catheters of the
implantable assembly for connecting a dialysis machine to a patient
of the present invention.
DESCRIPTION OF THE REFERENCED NUMERALS
Turning now descriptively to the drawings, in which similar
reference characters denote similar elements throughout the several
views, the Figures illustrate the implantable assembly for
connecting a dialysis machine to a patient of the present
invention. With regard to the reference numerals used, the
following numbering is used throughout the various drawing
figures.
10 implantable assembly for connecting a dialysis machine to a
patient of the present invention
12 patient
13 housing
14 face side of housing
15 first port
16 second port
18 third port
20 first conduit between first port and third port
22 second conduit between second port and third port
24 first passageway for connecting first port to a first
catheter
26 first catheter
28 second passageway for connecting second port to a second
catheter
30 second catheter
32 superior vena cava
34 heart
36 first securing device
38 second securing device
40 first connection port
42 second connection port
44 base section of first connection port
46 side wall of housing
48 connection section of first connection port
50 base section of second connection port
52 connection section of second connection port
54 first recess for receiving the first port
56 second recess for receiving the second port
58 third recess for receiving the third port
60 side wall of first recess
62 side wall of second recess
64 side wall of third recess
66 entrance to interior of first recess
68 entrance to interior of second recess
70 first sealing device
72 second sealing device
74 third sealing device
76 first right angle anti-coring needle
78 second right angle anti-coring needle
80 third right angle anti-coring needle
82 first end of first right angle anti-coring needle
84 second end of first right angle anti-coring needle
86 opening of first right angle anti-coring needle
88 first end of second right angle anti-coring needle
90 second end of second right angle anti-coring needle
92 opening of second right angle anti-coring needle
94 first end of third right angle anti-coring needle
96 second end of third right angle anti-coring needle
98 opening of third right angle anti-coring needle
100 recess in side wall of housing
102 protrusion extending from port and through recess
104 thread spiraling around protrusion
106 thread spiraling around inner side of base section of
connection port
108 side of protrusion
110 outlet catheter
112 compression sleeve
114 mid section of connection port
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Turning now descriptively to the drawings, in which similar
reference characters denote similar elements throughout the several
views, FIGS. 1 through 9 illustrate the implantable dialysis
connection assembly of the present invention indicated generally by
the numeral 10.
The implantable dialysis connection assembly 10 is illustrated in
FIG. 1 positioned below subcutaneous tissue in a left subclavicular
area of a patient 12. The implantable dialysis connection assembly
10 includes a housing 13. Held within the housing 13 and accessible
through a face side 14 thereof is a first port 15 for receiving a
first needle from a dialysis machine, a second port 16 for
receiving a second needle from the dialysis machine, and a third
port 18 for receiving and storing heparin therein. Heparin is an
anti-clotting agent which prevents the clotting of blood. The third
port 18 is connected to the first port 15 by a first conduit 20 and
is connected to the second port 16 by a second conduit 22. The
third port 18 supplies the heparin supplied via the third needle
and stored therein to both the first and second ports 15 and 16 via
the first and second conduits 20 and 22, respectively. The heparin
prevents blood passing through the first and second ports 15 and 16
from clotting and thereby clogging the ports 15 and 16.
Extending from the first port 15 is a first passageway 24 for
connection to a first catheter 26. A second passageway 28 extends
from the second port 16 for connection with a second catheter 30.
The first and second catheters 26 and 30, respectively, are both
positioned in a vein 32 supplying blood to the heart 34.
Preferably, the first and second catheters 26 and 30, respectively,
are positioned to extend into the superior vena cava of the patient
12. The superior vena cava supplies oxygen depleted blood from the
upper extremities to the heart 34. One of the first and second
catheters 26 and 30 will remove blood from the vein 32, supplying
the blood to a dialysis machine connected to one of the first and
second ports 15 and 16, respectively, for detoxification. The other
of the first and second catheters 26 and 30, respectively, will
return the detoxified blood to the vein 32 through the other of the
first and second ports 15 and 16, respectively, for supplying the
blood to the heart for pumping around the body of the patient.
The implantable dialysis connection assembly 10 is secured in
position by first and second securing devices 36 and 38,
respectively. The first and second securing devices 36 and 38 are
fastened in position below subcutaneous tissue in a left
subclavicular area of a patient 12 by either sutures or staples and
thereby is prevented from moving.
The face side 14 of the housing 13 of the implantable dialysis
connection assembly 10 is illustrated in FIG. 2. From this view the
first, second and third ports 15, 16 and 18 can be clearly seen.
The first and second conduits 20 and 22, respectively, are
illustrated in dashed lines. The first and second passageways 24
and 28 are also illustrated in dashed lines. Extending from the
first passageway 24 is a first connection port 40 for connection to
the first catheter 26 and extending from the second passageway 28
is a second connection port 42 for connection to the second
catheter 30. The first and second ports 15 and 16 may be used as
either an arterial (inflow) port or a venous (outflow) port
interchangeably dependent upon the terminal connections to the
dialysis machine. The first and second conduits 20 and 22,
respectively, provide a supply of heparin from the third port 18 to
the first and second ports 15 and 16, respectively, for preventing
blood flowing therethrough from clotting and thereby clogging the
first and second catheters.
The first and second securing devices 36 and 38 extend from the
housing 13 adjacent the first and second connection ports 40 and 42
for securing the implantable dialysis connection assembly 10 in
position. By securing the implantable dialysis connection assembly
10 at these locations, the connection between the first and second
catheters 26 and 30 and the first and second connection ports 40
and 42 are held secure and thus the possibility of the connection
therebetween being ruptured or broken is minimized.
A side view of the implantable dialysis connection assembly 10 is
illustrated in FIG. 3. From this view, the first and second
connection ports 42 and 44 are clearly seen. The first connection
port 40 includes a hollow base section 44 connected to a side wall
46 of the housing 13. Extending from the base section 44 is a
connection section 48 for connecting with the first catheter 26.
The connection section 48 is hollow and includes an inner side
having a circumference substantially equal to an inner
circumference of the hollow base section 44. The first catheter 26
has an outer circumference substantially equal to the circumference
of the connection section 48 for forming a tight seal therebetween.
The second connection port 42 includes a hollow base section 50
connected to the side wall 46 of the housing 13. Extending from the
base section 50 is a connection section 52 for connection to the
second catheter 30. The connection section 52 is hollow and
includes an inner side having a circumference substantially equal
to an inner circumference of the hollow base section 50. The second
catheter 30 has an outer circumference substantially equal to the
circumference of the connection section 52 for forming a tight seal
therebetween.
While a preferred structure and device for connecting the
implantable dialysis connection assembly 10 to a catheter are shown
and described herein, those of ordinary skill in the art who have
read the description will appreciate that there are numerous other
devices for connecting the implantable dialysis connection assembly
10 to a catheter and, therefore, as used herein the phrase "means
for connecting the implantable dialysis connection assembly to a
catheter" should be construed as including all such devices as long
as they achieve the desired result of connecting the implantable
dialysis connection assembly 10 to a catheter, and, therefore, that
all such equivalent mechanisms and combinations are to be
considered as equivalents to the ones described herein.
An exploded view of the implantable dialysis connection assembly 10
including the first, second and third ports removed therefrom is
illustrated in FIG. 4. As can be seen from this figure, the housing
13 includes a first recess 54 for receiving the first port 15, a
second recess 56 for receiving the second port 16 and a third
recess 58 for receiving the third port 18. The first recess 54
preferably has a slanted side wall 60 and the second recess 56 also
preferably has a slanted side wall 62. The side wall 64 of the
third recess 58 preferably extends perpendicular to the face side
14 of the housing 13. The side wall 60 of the first recess 54
includes an entrance 66 connecting an interior of the first recess
54 to the hollow base section 44 of the first connection device 40
thereby allowing communication between the first port 15 and the
first catheter 26. The side wall 62 of the second recess 56
includes an entrance 68 connecting an interior of the second recess
56 to the hollow base section 50 of the second connection device 42
thereby allowing communication between the second port 16 and the
second catheter 30.
The first, second and third ports 15, 16 and 18, respectively, are
preferably formed of a rubberized silicone material able to seal
any septum created by passage of a needle therethrough as occurs
when needles are inserted into the first and second ports for
connecting the implantable dialysis connection assembly 10 to a
dialysis machine. The first, second and third ports 15, 16 and 18,
respectively, may also be formed of any one of a sponge material,
foam, a rubberized material, any self sealing material and any
combination thereof. The first and second ports 15 and 16,
respectively, are thus able to absorb the heparin supplied by the
third port and any blood passing therethrough. The blood and
heparin are combined in the first and second ports and allowed to
pass therethrough either to a needle positioned therein connected
to the dialysis machine or to the catheter and vein from the needle
connected to the dialysis machine dependent upon the terminal
connections to the dialysis machine. The third recess 58 stores
heparin below the third port for providing a regulated supply to
the first and second ports. The first port 15 is retained within
the first recess 54 by a first sealing device 70, the second port
16 is retained in the second recess 56 by a second sealing device
72 and the third port 18 is retained in the third recess 58 by a
third sealing device 74.
The first, second and third ports 15, 16 and 18, respectively, are
illustrated removed from the housing 13 in FIG. 5. The first port
15 includes a first right angle anti-coring needle 76 removably
extending therefrom. The second port 16 includes a second right
angle anti-coring needle 78 removably extending therefrom. The
third port 18 includes a third right angle anti-coring needle 80
removably extending therefrom. The first right angle anti-coring
needle 76 includes a first end 82 for connection to a first
terminal of a dialysis machine and a second pointed end 84 for
extending into the first port 15. The first right angle anti-coring
needle 76 is hollow and includes an opening 86 for the passage of
blood therethrough. The second right angle anti-coring needle 78
includes a first end 88 for connection to a second terminal of a
dialysis machine and a second pointed end 90 for extending into the
second port 16. The second right angle anti-coring needle 78 is
hollow and includes an opening 92 for the passage of blood
therethrough. The third right angle anti-coring needle 80 includes
a first end 94 for connection to a supply of heparin and a second
pointed end 96 for extending into the third port 18. The third
right angle anti-coring needle 80 is hollow and includes an opening
98 for the passage of heparin therethrough. The heparin delivered
to and stored in the third port 18 is delivered to the first port
15 through the first conduit 20 and to the second port 16 via the
second conduit 22. The blood and heparin within the first recess 54
is passed between the first right angle anti-coring needle 76 and
the first conduit 20 via the first connection port 24. The blood
and heparin within the second recess 56 is passed between the
second right angle anti-coring needle 78 and the second conduit via
the second connection port 26.
A side cross-sectional view of the implantable dialysis connection
assembly 10 is illustrated in FIG. 6. A preferred connection
between the second port 16 and the second catheter 30 via the
second connection device 42 is clearly seen by this figure. The
description and illustration of the connection between the second
port 16 and the second catheter 30 is for purposes of illustration
only. The first port 15 and first catheter 26 may be connected in
the same manner. The base section 50 of the second connection port
42 is secured within a recess 100 extending into the side wall 46
of the housing 13. A protrusion 102 including a thread 104
spiraling therearound extends from the recess 100 and engages a
thread 106 spiraling around a portion of an inner side of the base
section 50 thereby securing the base section to the protrusion 102
and thus to the housing 13. The securing section 52 of the
connection port 42 extends from the housing 13 and receives the
catheter 30 therein. The catheter 30 is caused to extend completely
through the connection port 42 and sit flush against the entrance
68 to the second port 16. The catheter 30 is thus securely held
within the connection port 42 for retaining its contact with the
second port 16. The connection between the second and third ports
16 and 18, respectively, via the second conduit 22 is also depicted
in this figure. An enlarged view of the connection device 42
illustrated in FIG. 6 and contained within the circle labeled 7 is
also illustrated in FIG. 7.
While a preferred structure and device for connecting the catheter
to its respective port are shown and described herein, those of
ordinary skill in the art who have read the description will
appreciate that there are numerous other devices for catheter to
its respective port and, therefore, as used herein the phrase
"means for connecting the catheter to said port" should be
construed as including all such devices as long as they achieve the
desired result of connecting the catheter to its respective port,
and, therefore, that all such equivalent mechanisms and
combinations are to be considered as equivalents to the ones
described herein.
FIGS. 8 and 9 illustrate an exploded view of the connection between
the protrusion 102, connection port 40, 42 and catheter 26, 30.
From these figures it can be seen that the catheter 26, 30 is
extended through the connection port 40, 42 and positioned flush
against a side 108 of the protrusion 102 with an extending portion
of the protrusion forming an outlet catheter 110 positioned therein
upon connection. A compression sleeve 112 is preferably positioned
to surround the catheter 26, 30 between the catheter 26, 30 and the
connection port 40, 42 forming a tight seal therebetween for
preventing against leakage through the connection to the protrusion
102. The outlet catheter 110 is preferably formed of a metallic
substance. The connection port 40, 42 is preferably formed of one
of a plastic, Lucite, any polymeric material and any combination
thereof. The compression sleeve 112 is preferably formed of
silicone.
The protrusion 102 is hollow and preferably has an internal
diameter of substantially 2.6 mm, an outer diameter of
substantially 5.5 mm and a length of substantially 6 mm. The outlet
catheter is also hollow and preferably has an internal diameter of
substantially 2.0 mm, an outer diameter of substantially 2.6 mm and
a length of substantially 10 mm. The compression sleeve 112 is
hollow and preferably has an internal diameter of substantially 4.0
mm, an outer diameter of substantially 5.0 mm and a length of
substantially 8 mm. The base section 44, 50 of the connection port
40, 42 preferably has an internal diameter of substantially 5.5 mm,
an outer diameter of substantially 10 mm and a length of
substantially 12 mm. The connection section 48, 52 of the
connection port 40, 42 preferably has an internal diameter of
substantially 4.0 mm, an outer diameter of substantially 5 mm and a
length of substantially 4.0 mm. A mid section 114 of the connection
port 40, 42 preferably has an internal diameter within a range of
substantially 4.0 mm to substantially 5.5 mm, an outer diameter
within a range of substantially 5 mm to substantially 10 mm and a
length of substantially 3.0 mm. The catheter 26, 30 preferably has
an internal diameter of substantially 2.5 mm, an outer diameter of
substantially 3.9 mm and a length of substantially 50 cm.
The housing 13 is preferably substantially 2 cm thick and 8 cm wide
at its widest point. The first and second recesses 54 and 56
preferably have a diameter of substantially 3 cm and the third
recess 58 preferably has a diameter of 1.5 cm. The first, second
and third recesses are preferably substantially 1.8 cm deep. The
first and second ports 15 and 16 are preferably 1.2 cm thick and
sit in the first and second recesses 54 and 56 forming a pool
therebelow of a depth of substantially 0.6 cm. for receiving the
blood passing therethrough. The third port 18 is preferably 0.6 cm
thick and sits in the third recess such that a pool having a depth
of substantially 1.2 cm is formed therebelow for receiving and
storing heparin therein.
The first, second and third ports are lined with a suitably dense
material for preventing the needle from piercing their walls and
are formed from a self sealing material such as rubberized silicone
for preventing the release of any fluids therefrom except through
the needle inserted therein. The first and second ports are of a
surface area of a size able to provide a large number of insertion
points thereby allowing an area time to heal after puncture with
the needle.
The operation of the implantable dialysis connection assembly 10
will now be described with reference to the figures. In operation,
the implantable dialysis connection assembly 10 is prepared for
implantation below subcutaneous tissue in a left subclavicular area
of a patient 12. The first, second and third ports 15, 16 and 18
are positioned within their respective recess and the first and
second catheters 26 and 30 are connected to the first and second
connection ports 40 and 42 respectively. When the implantable
dialysis connection assembly 10 is implanted in the body of the
patient, the first and second catheters 26 and 30 are positioned to
extend into the superior vena cava of the patient 12 and the
securing devices 36 and 38 are sutured or stapled to the
subcutaneous tissue in the left subclavicular area of the patient
12. The implantable dialysis connection assembly 10 is now secured
within the body of the patient and ready for use. The implantable
dialysis connection assembly 10 may be located by simply feeling
around the area of implantation until located. The presence of the
implantable dialysis connection assembly 10 is easily
detectable.
When ready for use, the doctor will feel around the area of
implantation to locate the three ports. Upon finding the first port
15, the first needle 76 connected to a first lead from the dialysis
machine is inserted therein such that the first needle 76 extends
through the first port and into the pool formed therebelow. When
the second port 16 is located, the second needle 78 connected to a
second lead from the dialysis machine is inserted therein such that
the second needle 78 extends through the second port 16 and into
the pool formed therebelow. Upon finding the third port 18, the
third needle 80 connected to a heparin supply is inserted therein
such that the third needle 80 extends through the third port and
into the pool formed therebelow. As the size of the third port 18
is substantially smaller than the size of the first and second
ports 15 and 16 it is easily distinguished therefrom thereby
preventing accidentally connecting the heparin supply to either the
first or second ports. The function of the first and second ports
is interchangeable and thus distinguishing the first and second
ports is not necessary.
Once the needles are inserted into their respective ports the
patient is prepared to begin dialysis treatment. At this point the
heparin is supplied through the third needle 80 and stored in the
pool formed below the third port 18. The heparin supply will be
drawn into the first and second recesses through the first and
second conduits by osmosis. When the dialysis machine is turned on,
blood is drawn through one of the catheters and into either the
first or second port by a suction force exerted through one of the
first and second needles. The blood drawn into the dialysis machine
is detoxified and returned through the other of the first and
second needles. The detoxified blood is then deposited in the pool
in which the needle sits for mixing with the heparin drawn into the
pool from the third port and return to the superior vena cava
through the catheter connected thereto. As the operation of the
first and second ports is interchangeable, blood may be drawn from
or returned to the body through either of the first and second
ports. The only condition being as the blood is drawn through one
of the ports it is returned through the other. One port cannot
perform both operations concurrently.
Once the blood of the patient is detoxified, the dialysis machine
is turned off and the first, second and third needles are removed
from their respective ports. As the first, second and third ports
are formed of a sealable rubberized silicone material, the hole
formed by the insertion of the needle is resealed once the needle
is removed and thus the port is prepared for reuse. This also
allows the port to be used a substantial number of times without
the need for replacement thus increasing the life of the
implantable dialysis connection assembly 10.
From the above description it can be seen that the implantable
dialysis connection assembly 10 of the present invention is able to
overcome the shortcomings of prior art devices by providing an
implantable dialysis connection assembly 10 which is cosmetically
appealing to the user and allows the user to assume a normal life
style between dialysis treatments without the risk of epidermal
infection normally associated with tubes providing external access
to implanted catheters. The implantable assembly for connecting a
dialysis machine to a patient includes identical arterial and
venous ports which are easily locatable and discernible by
application of light pressure to the skin with a hand and are
accessible using right angle anti-coring needles attached to the
dialysis machine and a third heparin port connected to both the
arterial and venous ports for storing a supply of heparin therein
and supplying the heparin to the arterial and venous ports for
preventing the blood from clotting in the ports and thereby
clogging the ports. The arterial and venous ports have a surface
area of a size able to provide a large number of insertion points
thereby allowing an area time to heal after puncture with the
needle and are formed from a self sealing material such as
rubberized silicone for preventing the release of any fluids
therefrom except through the needle inserted therein. Each of the
arterial, venous and heparin ports are also lined with a suitably
dense material for preventing the needle from piercing the walls of
the port. Furthermore, the implantable dialysis connection assembly
10 of the present invention is simple and easy to use and
economical in cost to manufacture.
It will be understood that each of the elements described above, or
two or more together may also find a useful application in other
types of methods differing from the type described above.
While certain novel features of this invention have been shown and
described and are pointed out in the annexed claims, it is not
intended to be limited to the details above, since it will be
understood that various omissions, modifications, substitutions and
changes in the forms and details of the device illustrated and in
its operation can be made by those skilled in the art without
departing in any way from the spirit of the present invention.
Without further analysis, the foregoing will so fully reveal the
gist of the present invention that others can, by applying current
knowledge, readily adapt it for various applications without
omitting features that, from the standpoint of prior art, fairly
constitute essential characteristics of the generic or specific
aspects of this invention.
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